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New study suggests loosening strict comorbidity criteria would open trials to thousands of previously exempt patients

In Clinical Trials by Barbara Jacoby

By: Diane Mapes From: fredhutch.org How do you make cancer clinical trials available to more patients? A new study published today in JAMA Oncology and led by Dr. Joseph Unger at Fred Hutchinson Cancer Research Center offers a tantalizing solution: loosen up the strict eligibility criteria. Low clinical trial participation is a problem that’s plagued cancer researchers for decades, with …

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UIC drug crosses blood-brain barrier, now in clinical trials for cancer patients

In Clinical Trials by Barbara Jacoby

From: today.uic.edu A drug invented at the University of Illinois at Chicago is now being studied in humans as a treatment for difficult-to-treat and chemoresistant cancers including glioblastoma, or GBM, the deadliest type of brain tumor. UIC professor Irina Gaisina, one of the inventors of the drug, has been closely involved in its research and development, which began more than …

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Practice-changing clinical trial reduces long-term radiotherapy side effects in women with breast cancer

In Clinical Trials by Barbara Jacoby

From: icr.ac.uk Targeting or reducing the dose of radiotherapy for women with breast cancer after surgery can substantially reduce the side effects they experience, a large-scale clinical trial has shown. The trial also found some women were more likely to experience side effects than others – for example, women were more likely to report side effects if they were younger, …

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PrimeVax Immuno-Oncology Receives IND Permission From FDA

In Clinical Trials by Barbara Jacoby

Source: PrimeVax Immuno-Oncology, Inc. From: prnewswire.com PrimeVax Immuno-Oncology, Inc. announced today that the company has successfully received their Investigational New Drug (IND) Application permission from the FDA to begin running their first human clinical trial. “Our goal is simple: treat melanoma patients who have exhausted their options,” states Tony Chen, PrimeVax’s CEO. “It has been a long road, but we …

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Evelo Biosciences Announces Dosing of First Patient in Phase 1/2 Clinical Trial of EDP1503 in Combination with KEYTRUDA® (pembrolizumab) in Multiple Oncology Indications

In Clinical Trials by Barbara Jacoby

From: ptcommunity.com Evelo Biosciences, Inc. (NASDAQ:EVLO) (“Evelo”) a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, today announced that it has dosed the first patient in its Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy. EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of …

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Breast Cancer Drug Promising in Phase 3 Trial

In Clinical Trials by Barbara Jacoby

By: Steven Reinberg From: consumer.healthday.com For women with advanced breast cancer who carry the BRCA1 and BRCA2 gene mutations, an experimental drug could improve survival, a new study suggests. The BRCA mutations are linked with a greater risk for aggressive breast and ovarian cancer. The drug, talazoparib, works by blocking an enzyme called poly ADP ribose polymerase (PARP), thus preventing …

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Deciphera Pharmaceuticals Initiates a Phase 1b/2 Clinical Trial of Rebastinib in Combination with Carboplatin in Patients with Advanced or Metastatic Solid Tumors

In Clinical Trials by Barbara Jacoby

Source: Deciphera Pharmaceuticals, Inc. From: apnews.com Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced that it has initiated an open-label, multicenter, Phase 1b/2 study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, in combination with carboplatin in patients with advanced or metastatic solid tumors. …

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Marker Therapeutics Provides Updates of its Lead Clinical Programs

In Clinical Trials by Barbara Jacoby

Source: Marker Therapeutics, Inc. From: prnewswire.com Reports clinical data updates with MultiTAA T cells in lymphoma, multiple myeloma and acute lymphoblastic leukemia Reports completion of enrollment for TPIV200 Phase II study in ovarian cancer Reports interim immunogenicity findings of TPIV200 Phase II study in triple negative breast cancer Marker Therapeutics, Inc. (NASDAQ: MRKR), a clinical-stage immuno-oncology company specializing in the development …

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Novartis investigational BYL719 (alpelisib) plus fulvestrant consistently improved PFS in patients with PIK3CA mutated HR+/HER2- advanced breast cancer in new SOLAR-1 analyses

In Clinical Trials by Barbara Jacoby

Source: Novartis From: prnewswire.com – BYL719 plus fulvestrant meaningfully prolonged PFS vs fulvestrant alone in patients with PIK3CA mutated HR+/HER2- advanced breast cancer after progression on an aromatase inhibitor or after receiving up to one additional line of therapy1 – SOLAR-1 is the first Phase III breast cancer trial to demonstrate potential viability of using liquid biopsy to select patients …

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First-in-human Study of Precision Immune Stimulant PIN-2 Demonstrated Pharmacologic Activity and Safety in Patients with Advanced Solid Tumors

In Clinical Trials by Barbara Jacoby

Source: PIN Pharma, Inc. From: argus-press.com PIN Pharma, Inc., today announced final results of a first-in-human clinical trial of its novel immunomodulating agent PIN-2 in subjects with advanced solid tumors. This was an open-label, repeat-dose study with a primary objective to assess the pharmacodynamic activity of PIN-2. Pharmacodynamic biomarkers that signal changes in the human immune system were used to …